MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PXT261414
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional devices implanted and/or related to this event: pxc141400/(b)(4), pxl161407/(b)(4) and pxc161000/(b)(4).
Event or Problem Description
On (b)(6) 2010, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported the excluder® aaa endoprostheses were explanted on (b)(6) 2018, and replaced with an open repair.The aneurysm sac had continued expansion over the past year for unknown reason.The patient tolerated the procedure.
Event or Problem Description
The aneurysm sac had continued expansion over the past year for unknown reason.Previous attempts to halt aneurysm sac expansion (dates unknown) including coiling the aneurysm sac and coiling the lumbar arteries were unsuccessful.
Additional Manufacturer Narrative
Addition-the devices were returned to w.L.Gore & associates for investigation.Submitted unfixed were three gore® excluder® aaa endoprostheses; one trunk ¿ ipsilateral leg endoprosthesis (trunk), two contralateral leg endoprostheses (cl-1 and cl-2).There was one iliac extender endoprosthesis (pxl161407) which was reported as part of the event however was not present as part of the returned specimen.The lumens of all devices were widely patent.Encircling the mid region of the endoprosthesis system was a firm red-brown mass highly consistent with aneurysmal sac contents.The visible abluminal regions of the devices had scattered plaques of friable red brown material present.A vertical transection through wire and graft material was present at the level of the trunk bifurcation.High resolution radiographs revealed the legs were held in a crossed configuration: cl-1 was contained within the contralateral gate of the trunk and cl-2 was contained within the ipsilateral leg of the trunk.No wire disruptions were noted on radiographs, with the exception of the device transection.A histopathological examination of the tissue could not be performed due to the lack of proper fixation prior to arrival at w.L.Gore & associates.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices were examined for material disruptions with the aid of a stereomicroscope.Observed stent frame and graft material disruptions were consistent with manipulation by surgical instrumentation (e.G., scissors).Constraint sleeve fray (cl-1 & cl-2) and material hairing (cl-2) were; these findings do not compromise device material integrity.Addition h6: code 213-the review of the manufacturing paperwork verified that these lots met all pre-release specifications.Addition h6: code 22-per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to surgical conversion.
Event or Problem Description
It was reported the excluder® aaa endoprostheses were explanted on (b)(6) 2018, and replaced with an open repair.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7628062
• Report Number: 2017233-2018-00333
• Device Sequence Number: 14062460
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: PXT261414
• Device Lot Number: 8170472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 06/17/2019; 06/17/2019; 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR